MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that right when the patient got the pump in 2013, also reported as ¿a month or two after it was put in, probably before she had to take off that big brace,¿ it went in a slant and the patient¿s healthcare provider (hcp) told the patient not to worry about that.Then the last time it happened, it went through the stitches and they reportedly fixed it.The pump system was being used to infuse an unknown medication at the time of the event.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), product type: catheter.(b)(4).

Event Description

Additional information received reported that the patient was still having concerns with their device or therapy but had not sought further help.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4606458
• MDR Text Key: 5761089
• Report Number: 3004209178-2015-04792
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2015
• Date Device Manufactured: 09/08/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention